Breakthroughs Blog: Medicines

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.A World Health Organization (WHO) draft document indicates that the WHO-led Access to COVID-19 Tools (ACT) Accelerator’s drug-supply scheme is prioritizing experimental antibody treatments and steroids while leaning away from remdesivir. The mechanism—one of four ACT Accelerator pillars working to scale COVID-19 health technologies—is co-led by Unitaid and the Wellcome Trust and is dedicated to securing and supplying COVID-19 therapeutics worldwide with an emphasis on equitable distribution. The scheme’s list of priorities outlined in the draft document says efforts will focus on advancing research and manufacturing of monoclonal antibodies and boosting distribution of the steroid dexamethasone, and does not mention remdesivir among priority drugs. The therapeutics pillar is also still working to reach its US$7.2 billion funding goal, $6.1 billion of which is unmet, and aims to distribute hundreds of millions of COVID-19 treatment regimens to lower-income countries by 2022.A recent analysis from researchers at Duke University’s Global Health Innovation Center found that high- and middle-income countries have purchased 3.8 billion COVID-19 vaccine doses, with options for 5 billion more, potentially leaving people in low-income countries without access until 2024. The study suggests that these direct deals between countries and drug manufacturers, known as advance purchase agreements, are exacerbating “vaccine nationalism” and undermining the equitable distribution efforts of mechanisms like the COVID-19 Vaccines Global Access (COVAX) Facility, a sub-mechanism of the ACT Accelerator. More than 150 countries, including many that have also made separate country-specific vaccine deals, have signed on to join the COVAX Facility, which aims to develop and equitably distribute 2 billion vaccine doses by the end of 2021.A nasal spray under development to prevent COVID-19 infection was shown to be effective in blocking absorption of SARS-CoV-2 in ferrets exposed to the virus, according to a research team from Columbia University Medical Center, Erasmus Medical Center, and Cornell University. The spray is designed to intervene in the virus’ process of attaching to airways or lung cells by fusing itself to an amino acid chain on the virus’ spike protein, thereby blocking viral attachment. In the very small animal study, the spray prevented all direct-contact transmission of SARS-CoV-2 during a 24-hour exposure period, indicating potential for the product to protect against COVID-19 infection in humans, although the research is still preprint and pre-peer review. Based on the promising animal results, researchers hope to secure additional funding that would allow them to expand tests of the nasal spray into human trials.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Regeneron will need to place on hold enrollment of patients requiring high-flow oxygen or mechanical ventilation in its COVID-19 antibody cocktail clinical trial, based on recommendations from an independent data monitoring committee. The trial can continue to enroll hospitalized patients who need either no or low-flow oxygen, and the treatment’s outpatient trial will continue unaffected. Early data on the antibody cocktail, REGN-COV2, indicated it reduced COVID-19–related medical visits by 57 percent. The cocktail is currently under evaluation by the US Food and Drug Administration for emergency use authorization, specifically in mild to moderate outpatients at high risk for poor outcomes.Singapore-based startup firm Breathonix has developed a breathalyzer test able to diagnose COVID-19 infection in under a minute. The device, designed to avoid cross-contamination, uses disposable mouthpieces and assesses the chemical compounds of the breath to determine infection. Results are then generated by a computer within 60 seconds. The test achieved more than 90 percent accuracy in a pilot clinical trial of 180 people, according to Breathonix, and could act as a first-level screening device with a more sensitive polymerase chain reaction nasal swab test used to confirm the diagnosis. The company will be expanding its trial in Singapore with the intention of improving accuracy and receiving a green light for commercial use in the first quarter of next year.Sanofi and GlaxoSmithKline (GSK) announced an agreement to supply 200 million doses of their COVID-19 vaccine candidate, if approved by regulators, to the COVID-19 Vaccine Global Access (COVAX) Facility. The vaccine candidate began a phase 1/2 clinical trial in early September, and first results are anticipated in December 2020 to support a phase 3 trial before the end of the year. Sanofi and GSK, in statements on the COVAX partnership, emphasized a commitment to ensuring affordable and accessible COVID-19 vaccines around the world. The COVAX Facility—a global collaboration of governments, global health organizations, businesses, and philanthropic organizations focused on accelerating development and production of COVID-19 products—is designed to ensure people in all parts of the world get access to COVID-19 vaccines once available. More than 180 countries and economies are currently a part of the mechanism.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. Moderna announced last week that it would “not enforce” its COVID-19–related patents against other vaccine makers and would be willing to license intellectual property for COVID-19 vaccines for the post-pandemic period. The company, which is currently developing one of the four front-running COVID-19 vaccine candidates, said in a statement that it feels a “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.” Some advocates have responded with praise for Moderna being the only company working on a drug or vaccine to pledge open-sharing of its COVID-19 patents, while other advocates question the motivations behind the pledge, given Moderna’s pending intellectual property legal challenges as well as recent consumer and political pressures for access. Moderna plans to submit its vaccine candidate for US Food and Drug Administration (FDA) emergency use authorization by November 25 and later as a candidate for the general population by late January 2021, with the aim of having it available for widespread distribution by spring 2021.BioNTech and Pfizer have begun a rolling submission of their COVID-19 vaccine candidate for review by the European Medicines Agency (EMA), a process that AstraZeneca’s vaccine candidate also began the previous week. The candidate, BNT162b2, was accepted for rolling review based on its strong preclinical and early clinical data, which showed antibody and T-cell responses in people dosed in early-phase trials. BioNTech and Pfizer subsequently launched a phase 3 clinical trial—so far enrolling 37,000 participants across several countries. EMA will start assessing data on the experimental candidate before all necessary evidence is available, allowing it to reduce time spent on a decision once pivotal clinical trial results are available.A monoclonal antibody treatment developed by Eli Lilly appears to be effective in reducing virus levels and preventing hospital use in COVID-19 patients. The treatment, a combination of two monoclonal antibodies, was tested in non-hospitalized patients sick with COVID-19. Eli Lilly is also developing and had previously released results for a similar treatment using a single antibody, for which the company has filed for FDA emergency use authorization. Both antibody regimens have been well-tolerated, with no serious side effects, according to a company statement. Eli Lilly has said it expects to file for emergency use authorization for its combination therapy next month and anticipates having 1 million single-antibody treatment doses and 50,000 combination treatment doses available in the fourth quarter of 2020.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email. As COVID-19 vaccine trials continue and expand, several plans for allocation of an approved vaccine are being formed. Preliminary guidance from a strategic advisory group at the World Health Organization, which some experts have said needs more detail before it can be actionable, outlines groups of people who should have priority access to vaccines and urges high-income countries to ensure that low- and middle-income countries receive vaccines early in allocation. Draft recommendations from the National Academies of Sciences, Engineering, and Medicine, developed in response to requests from the Centers and Disease Control and Prevention and National Institutes of Health for vaccine allocation in the United States, also outlines priority groups, but goes a step further to rank those groups in a tiered approach, starting with health care workers and first responders. Both strategies address and emphasize vaccine access for disadvantaged groups, and both plans will continue to be developed in the upcoming months.Computer vision startup Gauss and biotech company Cellex recently announced their development of the first rapid COVID-19 diagnostic test able to be performed fully at home, with no laboratory involvement. The antigen test, developed by Cellex, requires its user to take a nasal swab from both nostrils and then place the swab in a small vial filled with a buffer solution. An AI app, developed by Gauss, then analyzes a picture of the rapid test to deliver results within 15 minutes. The test is still under development, and the companies will be pursuing US Food and Drug Administration emergency use authorization in upcoming months with the hopes of making the tool “as widely available as possible.”Preliminary results from a 1,000-person study indicated positive results for Eli Lilly’s anti-inflammatory treatment in shortening COVID-19 recovery time. The study, sponsored by the National Institute for Allergy and Infectious Diseases, tested Eli Lilly’s rheumatoid arthritis drug baricitinib in combination with Gilead’s remdesivir, which has previously been shown to reduce COVID-19 recovery time. The results announced last week, which have not yet been published or reviewed by independent scientists, showed participants given baricitinib recovered one day sooner than those given remdesivir alone. Eli Lilly plans to pursue emergency use approval of the drug for hospitalized COVID-19 patients and, if approved, proposes selling it through its normal commercial means.